Method of affecting sleep and sleep-related behaviors

• US 20030225095A1
• Filed: 02/04/2003
• Published: 12/04/2003
• Est. Priority Date: 02/08/2002
• Status: Abandoned Application

• Current Assignee: Johnson & Johnson Consumer Companies Incorporated (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Consumer Companies Incorporated (Johnson & Johnson)
• Inventors: Wiegand, Benjamin, McCulloch, Laura
• Application Number:
  US10/357,648
• Publication Number:
  US 20030225095A1
• Time in Patent Office: Days
• US Class Current: 514/249
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61K 38/2228 Corticotropin releasing factor [CRF] (Urotensin)
• CPC Class Codes: A61M 2021/0016 by the smell sense
• CPC Class Codes: A61M 2021/0022 by the tactile sense, e.g. vibrations
• CPC Class Codes: A61M 2021/0027 by the hearing sense
• CPC Class Codes: A61M 2021/0044 by the sight sense
• CPC Class Codes: A61M 21/00 Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 27/10 for accommodation disorders, e.g. myopia
• CPC Class Codes: A61P 5/02 of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin

Abstract

A method of affecting sleep and sleep-related behaviors of a mammal having a diurnal rhythm, by reducing the basal activity of the hypothalamus-pituitary-adrenal axis by administering an effective amount of a sensory regimen is disclosed. Such reduction may be accomplished by reducing at least one of the following:

a. the average total daily amount of adrenocortical hormone; or

b. the average total daily amount adrenocortical hormone minus the integrative measure of morning peak adrenocortical hormone.

Preferably, such reduction also includes reducing at least one of the following:

c. the level of adrenocortical hormone 4 hours to 8 hours after waking;

d. the level of adrenocortical hormone in the period of time preceding bedtime; or

e. the level of adrenocortical hormone below the onset of sleep threshold.

Claims

1. A method of affecting sleep and sleep-related behaviors in a mammal having a diurnal rhythm, comprising the step of:

reducing the basal activity of the HPA axis of said mammal;

wherein said HPA axis, comprises;

a. levels of adrenocortical hormone present as a function of time in said diurnal rhythm of said mammal;

b. a total daily amount of adrenocortical hormone;

c. an integrative measure of morning peak adrenocortical hormone; and

d. an onset of sleep threshold.

2. A method of affecting sleep and sleep-related behaviors in a mammal having a diurnal rhythm, comprising the step of:

reducing the basal activity of the HPA axis of said mammal,

wherein said reducing step, comprises administering an effective amount of a sensory regimen to said mammal; and

wherein said HPA axis, comprises;

a. level of adrenocortical hormone present as a function of time in said diurnal rhythm of said mammal;

b. a total daily amount of adrenocortical hormone;

c. an integrative measure of morning peak adrenocortical hormone; and

d. an onset of sleep threshold.

3. The method of claim 2, wherein said reducing step is at least one step selected from the group consisting of:

a. reducing said average total daily amount of adrenocortical hormone in said mammal; and

b. reducing said average total daily amount adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone in said mammal.

5. The method of claim 2, wherein said reducing step further comprises at least one step selected the group consisting of:

a. reducing said level of adrenocortical hormone in said mammal 4 hours to 8 hours after waking;

b. reducing said level of adrenocortical hormone in said mammal in the period of time preceding bedtime; and

c. reducing the level of adrenocortical hormone in said mammal below said onset of sleep threshold.

6. The method of claim 2, wherein said adrenocortical hormone is cortisol.

7. The method of claim 3, wherein said average total daily amount is reduced by at least about 5% to about 50%, based on the total daily amount of adrenocortical hormone present in said mammal at the start of said regimen.

8. The method of claim 3, wherein said average total daily amount is reduced by at least about 10% to about 40%, based on the total daily amount of adrenocortical hormone present in said mammal at the start of said regimen.

9. The method of claim 3, wherein said average total daily amount is reduced by at least about 15% to about 30%, based on the total daily amount of adrenocortical hormone present in said mammal at the start of said regimen.

10. The method of claim 3, wherein said average total daily amount of adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone is reduced by at least about 5% to about 70%, based on the total daily amount of adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone present in said mammal at the start of said regimen.

11. The method of claim 3, wherein said average total daily amount of adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone is reduced by at least about 10% to about 60%, based on the total daily amount of adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone present in said mammal at the start of said regimen.

12. The method of claim 3, wherein said average total daily amount of adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone is reduced by at least about 20% to about 50%, based on the total daily amount of adrenocortical hormone minus said integrative measure of morning peak adrenocortical hormone present in said mammal at the start of said regimen.

14. The method of claim 5, wherein said level of adrenocortical hormone 4 hours to 8 hours after waking is reduced by at least about 5% to about 70%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

16. The method of claim 5, wherein said level of adrenocortical hormone 4 hours to 8 hours after waking is reduced by at least about 10% to about 60%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

18. The method of claim 5, wherein said level of adrenocortical hormone 4 hours to 8 hours after waking is reduced by at least about 20% to about 50%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

20. The method of claim 5, wherein said level of adrenocortical hormone preceding bedtime is reduced by at least about 3% to about 50%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

22. The method of claim 5, wherein said level of adrenocortical hormone preceding bedtime is reduced by at least about 5% to about 30%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

24. The method of claim 5, wherein said level of adrenocortical hormone preceding bedtime is reduced by at least about 5% to about 20%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

26. The method of claim 5, wherein said level of adrenocortical hormone is reduced to less than 0.3 micrograms/deciliter.

28. The method of claim 5, wherein said level of adrenocortical hormone is reduced to less than 0.2 micrograms/deciliter.

30. The method of claim 5, wherein said level of adrenocortical hormone is reduced to less than 0.15 micrograms/deciliter.

31. The method of claim 2, wherein said sensory regimen further comprises at least one step selected from the group consisting of:

a. administering at least one CRH antagonist;

b. administering at least one anti-depressant; and

c. administering at least one pharmacological sleep aid.

32. The method of claim 2, wherein basal activity of the HPA axis of said mammal is reduced within a period of 2 days to 14 days from the start of said regimen.

33. The method of claim 2, wherein said sensory regimen is selected from the group consisting of auditory stimuli, visual stimuli, tactile stimuli, gustatory stimuli and olfactory stimuli, and combinations thereof.

4. A method of affecting sleep and sleep-related behaviors in a mammal having a diurnal rhythm, comprising at least one step selected from the group consisting of:

a. reducing the level of adrenocortical hormone in said mammal 4 hours to 8 hours after waking;

b. reducing the level of adrenocortical hormone in said mammal in the period of time preceding bedtime; and

c. reducing the level of adrenocortical hormone in said mammal below said onset of sleep threshold.

13. The method of claim 4, wherein said level of adrenocortical hormone 4 hours to 8 hours after waking is reduced by at least about 5% to about 70%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

15. The method of claim 4, wherein said level of adrenocortical hormone 4 hours to 8 hours after waking is reduced by at least about 10% to about 60%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

17. The method of claim 4, wherein said level of adrenocortical hormone 4 hours to 8 hours after waking is reduced by at least about 20% to about 50%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

19. The method of claim 4, wherein said level of adrenocortical hormone preceding bedtime is reduced by at least about 3% to about 50%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

21. The method of claim 4, wherein said level of adrenocortical hormone preceding bedtime is reduced by at least about 5% to about 30%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

23. The method of claim 4, wherein said level of adrenocortical hormone preceding bedtime is reduced by at least about 5% to about 20%, based on the level of adrenocortical hormone present during that same time period in the mammal at the start of the regimen.

25. The method of claim 4, wherein said level of adrenocortical hormone is reduced to less than 0.3 micrograms/deciliter.

27. The method of claim 4, wherein said level of adrenocortical hormone is reduced to less than 0.2 micrograms/deciliter.

29. The method of claim 4, wherein said level of adrenocortical hormone is reduced to less than 0.15 micrograms/deciliter.