Prolonged apnea risk evaluation

• US 6,059,725 A
• Filed: 08/05/1998
• Issued: 05/09/2000
• Est. Priority Date: 08/05/1997
• Status: Expired due to Fees

• Current Assignee: American Sudden Infant Death Syndrome Institute
• Original Assignee: American Sudden Infant Death Syndrome Institute
• Inventors: Steinschneider, Alfred
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): ASTORINO, MICHAEL C
• Application Number:
  US09/129,566
• Time in Patent Office: 643 Days
• Field of Search: 600/300-301, 600/479-483, 600/322-325, 600/481, 600/485, 600/500, 600/509, 600/527, 600/528, 600/529-542, 600/587, 600/590, 128/897-899, 128/903
• US Class Current: 600/300
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/4818 Sleep apnoea

Abstract

A method for determining the probability of an episode of prolonged apnea in an infant less than or equal to 6 months of age has been developed. The method includes conducting a physiological feeding study wherein the subject is bottle fed while monitoring respiration, heart rate, O₂ saturation, and sucking pressure, conducting a sleep study wherein the subject is allowed to sleep naturally while monitoring respiration, heart rate, O₂ saturation, and brain activity, and analyzing the data to make a prediction of the probability of a prolonged episode of sleep apnea. The method can further include correlating the results of the physiological feeding study and the sleep study with age, epidemiologic characteristics, and birth age. In the preferred embodiment, the sleep study is conducted in an environmentally controlled test chamber at 90°±2° F., and both respiratory effort and air flow are measured.

Claims

1. A method for determining a probability of an episode of prolonged apnea in an infant subject less than or equal to 6 months of age comprising:

(a) conducting a physiological feeding study wherein the subject is bottle fed while monitoring respiration, heart rate, O₂ saturation, and sucking pressure, and

(b) conducting a sleep study wherein the subject is allowed to sleep naturally while monitoring respiration, heart rate, O₂ saturation, and brain activity,

(c) correlating results of the physiological feeding study and the sleep study with age, epidemiologic characteristics, and birth age, and,

(d) analyzing correlated data from the physiolozical feeding study and the sleep study to make a determination of the probability of a prolonged episode of sleep apnea.

2. The method of claim 1 wherein the sleep study is conducted in an environmentally controlled test chamber at 90°

±

2°

F.

3. The method of claim 1 further comprising measuring both respiratory effort and air flow.

4. The method of claim 1 further comprising making an EKG.

5. The method of claim 1 comprising determining A2/D %, wherein A2/D % is the summed duration of apneic pauses greater than or equal to 2 sec divided by the duration of sleep times 100.

6. The method of claim 1 further comprising determining the PSA4, where PSA4=-2.695+0.607 (MT)+0.023(AR)+0.042 (AN)-0.143 (A2/D %),

where:

MT is mean duration of apnea in total sleep

AR is % of REM epochs during which apnea ≧

2 sec was initiated,

AN is % of NREM epochs during which apnea ≧

2 sec was initiated, and

A2/D % is the summed duration of apneic pauses greater than or equal to 2 sec divided by the duration of sleep times 100.

7. The method of claim 1 further comprising determining A6/D %, where A6/D % is summed duration of apneic pauses greater than or equal to six sec divided by the duration of sleep times 100.

8. The method of claim 1 further comprising determining a longest airway obstruction (MO) episode (REM, NREM, Total).

9. The method of claim 1 further comprising determining MO2%, wherein MO2% is percentage of airway obstruction episodes greater than or equal to two sec initiated within REM epochs, NREM epochs, and Total sleep.

10. The method of claim 1 further comprising determining MO2/D %, where MO2/D % is the summed duration of airway obstruction episodes ≧

2 sec divided by the duration of sleep times 100.

11. The method of claim 1 further comprising determining MO6%, where MO6% is the percentage of airway obstruction episodes (≧

6 sec) initiated within REM epochs, NREM epochs, and Total sleep.

12. The method of claim 1 further comprising determining MO6/D %, where MO6/D % equals the summed duration of airway obstruction episodes ≧

6 sec divided by the duration of sleep times 100.