Trial Outcomes & Findings for Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea (NCT NCT04299009)

NCT ID: NCT04299009

Last Updated: 2025-02-03

Results Overview

Number of participants recruited, number of participants retained, number of participants with complete data

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: baseline to week 9
• Results posted on: 2025-02-03

Participant Flow

The available effective window for recruitment of participants was drastically reduced by the pandemic, during which all research activities and non essential clinical contact was place on hold

Participant milestones

Measure	Sham-Bright Light Therapy (sBLT) First, Then BLT Participants received sBLT therapy via Retimer glasses with a neutral density filter applied to the led lights, thus blocking 85% of the light intensity for 4 weeks, followed by BLT	Bright Light Therapy (BLT) First, Then sBLT Participants received BLT via Retimer glasses for 4 weeks, followed by 4 weeks of sBLT
First Intervention (4 Weeks) STARTED	9	6
First Intervention (4 Weeks) COMPLETED	8	6
First Intervention (4 Weeks) NOT COMPLETED	1	0
Second Intervention (4 Weeks) STARTED	8	6
Second Intervention (4 Weeks) COMPLETED	8	6
Second Intervention (4 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	sBLT Then BLT n=9 Participants sBLT first, followed by BLT	BLT Then sBLT n=6 Participants BLT first, followed by sBLT	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	54.8 years STANDARD_DEVIATION 5 • n=5 Participants	54.8 years STANDARD_DEVIATION 5 • n=7 Participants	54.8 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 9

Number of participants recruited, number of participants retained, number of participants with complete data

Outcome measures

Measure	sBLT-BLT n=9 Participants sBLT first, followed by BLT	BLT-sBLT n=6 Participants BLT first, followed by sBLT
Feasibility of Recruitment and Retention Completers	8 participants	6 participants
Feasibility of Recruitment and Retention Number of subjects with complete data	8 participants	6 participants

PRIMARY outcome

Timeframe: pre- treatment=baseline; post-treatment=4 weeks

Brief self report questionnaire used to quantify degree of daytime sleepiness. Minimum score is 0,maximum score is 24; values below 10 are considered normal

Outcome measures

Measure	sBLT-BLT n=14 Participants sBLT first, followed by BLT	BLT-sBLT n=14 Participants BLT first, followed by sBLT
Epworth Sleepiness Scale Epworth pretreatment	13.2 score on a scale Standard Deviation 4	12.3 score on a scale Standard Deviation 4
Epworth Sleepiness Scale Epworth post treatment	12 score on a scale Standard Deviation 4.9	10.8 score on a scale Standard Deviation 4

SECONDARY outcome

Timeframe: pre-treatment=baseline; post-treatment=4 weeks

Assesses impact of sleep related disturbances on daily functioning. It is a likert scale whose scaling of items is from zero to four. The potential range of scores for the total score is 5-20, with higher scores indicating worse functioning

Outcome measures

Measure	sBLT-BLT n=14 Participants sBLT first, followed by BLT	BLT-sBLT n=14 Participants BLT first, followed by sBLT
Functional Outcomes of Sleep Questionnaire (FOSQ-10) FOSQ pre treatment	24 score on a scale Standard Deviation 5	28.6 score on a scale Standard Deviation 3.2
Functional Outcomes of Sleep Questionnaire (FOSQ-10) FOSQ post treatment	30 score on a scale Standard Deviation 5.3	29.5 score on a scale Standard Deviation 9

Adverse Events

Sham-Bright Light Therapy (sBLT)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Bright Light Therapy (BLT)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sham-Bright Light Therapy (sBLT) n=14 participants at risk sham bright light therapy first, follow by one week wash out and them active bright light therapy Active treatment: Bright light therapy delivered through Retimer glasses. Sham treatment: neutral density filter blocking 80% of light intensity applied to Retimer glasses.	Bright Light Therapy (BLT) n=14 participants at risk active bright light therapy first, followed by one week wash out and then sham Bright light therapy Active treatment: Bright light therapy delivered through Retimer glasses. Sham treatment: neutral density filter blocking 85% of light intensity applied to Retimer glasses.
General disorders Headache	7.1% 1/14 • Number of events 1 • Each participants was assessed for a total of 10 weeks max from consent signing to end of the study. consistent with clinicaltrials.gov definition	7.1% 1/14 • Number of events 1 • Each participants was assessed for a total of 10 weeks max from consent signing to end of the study. consistent with clinicaltrials.gov definition

Additional Information

Isabella Soreca

Pittsburgh VA Healthcare System

Phone: 412 3606815

Email: Isabella.Soreca@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place